The data showed MAEs onset was significantly faster with atorvastatin and rosuvastatin compared with simvastatin; a comparison with other statins could not be established due to the small number of cases identified.

The likelihoods of nonadherence and discontinuation were increased in association with diabetes, while hypertension, angina, and congestive heart failure correlated with a reduced likelihood of nonadherence and discontinuation.

Specifically, the panel recommends that testing include the genes encoding the low-density lipoprotein receptor, apolipoprotein B, and proprotein convertase subtilisin/kexin 9. Depending on patient phenotype, other genes may also need to be considered for analysis.

“We are extremely disappointed with the FDA’s decision. We continue to feel strongly that Waylivra demonstrates a favorable benefit/risk profile in people with FCS,” said Akcea CEO, Paula Soteropoulos.